Multicentre randomised phase II trial of gemcitabine+platinum, with or without trastuzumab, in advanced or metastatic urothelial carcinoma overexpressing Her2.

Aim: To investigate the efficacy and safety of gemcitabine and platinum salt, with or without trastuzumab, in patients with locally advanced or metastatic urothelial carcinoma overexpressing Her2.

Methods: The main eligibility criterion was Her2 overexpression on immunohistochemistry (IHC 2+ or 3+) of primary tumour tissue confirmed by fluorescence in situ hybridisation (FISH). Patients were randomised to Arm A: gemcitabine 1000mg/m(2) (days 1 and 8) plus either cisplatin (70mg/m(2)) or carboplatin (AUC=5) (day 1 every 3 weeks) or Arm B: added trastuzumab (8mg/kg loading dose, then 6 mg/kg every 21 days until progression).

Comparison of fifteen immunoassays for the measurement of serum MUC-1/CA 15-3 in breast cancer patients.

Background: Quality control results for serum MUC-1/CA 15-3 assays have always shown large discrepancies.

Methods: This multicentre study of 15 methods (labelled M1-M15) measured coded sera from 35 patients with breast cancer without recurrence (group 1), 46 patients at 1st metastasis (group 2), and 39 patients with advanced metastases (group 3). Results were compared using parametric statistics, ANOVA, principal component analysis, and receiver operating characteristic (ROC) curves.

Serum HER-2/neu and relative resistance to trastuzumab-based therapy in patients with metastatic breast cancer.

Background: Previous reports based on small patient numbers suggested that changes in serum HER-2/neu levels may predict response or lack of response to trastuzumab-based therapies in metastatic breast cancer (MBC). The objectives of this study were to pool data from 307 patients with MBC from 7 medical institutions to validate that the serum HER-2/neu profile predicts patient resistance to trastuzumab and to establish a clinically relevant cutoff.

Methods: This was an international, multicenter, retrospective analysis of individual pooled data from 307 patients with MBC who were treated with first-line trastuzumab-based therapy.

Variations of soluble fas and cytokeratin 18-Asp 396 neo-epitope in different cancers during chemotherapy.

Soluble Fas (sFas) and cytokeratin 18-Asp396 neoepitope (CK18-NE) were measured by ELISA in serial samples from 42 patients with different cancers under chemotherapy and were compared with pharmacokinetic results. Baseline sFas (median 6146 pg/ml, range 3123-16294 pg/ml) was higher in cancer patients than in normal subjects (median 4954 pglml, range 2595-10565 pg/ml, n =95) (p <0.01) and increased with the number of previous chemotherapy lines (p =0.

[FDG (18 fluorodeoxyglucose) positron emission tomography and breast cancer].

Positron emission tomography (PET) is a metabolic radionuclide imaging method in which a tracer labeled with a positron emitter is detected with a dedicated system. 18F-fluorodeoxyglucose (FDG) accumulates in tumor cells because of their increased glycolytic activity, and is thus widely used as a tracer in oncology. This increased metabolic activity precedes morphologic modifications, making FDG-PET a very useful tool for detecting and staging cancer.

A soluble lymphocyte activation gene-3 (sLAG-3) protein as a prognostic factor in human breast cancer expressing estrogen or progesterone receptors.

In contrast to the long-held belief that breast cancer is a weakly immunogenic tumor, accumulating evidence indicates an immune infiltrate is an invariable finding in breast cancers, raising hopes that immunotherapy for breast cancers may succeed in targeted patients, specifically those with either regional or minimal residual disease. However, no immunologically related prognostic factor has yet been established that may help to define subsets of patients who are more prone to respond to immunotherapy. High levels of soluble LAG-3 protein (sLAG-3) in sera has previously been shown to be associated, as a Th1 marker, to resistance to tuberculosis in large series of patients.

Longitudinal changes in serum HER-2/neu oncoprotein levels in trastuzumab-treated metastatic breast cancer patients.

Background: To evaluate longitudinal variations of serum HER-2/neu extracellular domain (sHER-2) in metastatic breast cancer patients receiving combined trastuzumab treatment.

Patients And Methods: Thirty-three patients were monitored by serial sHER-2 ELISA (Oncogene Science). Results were compared to time to progression (TTP) and survival from treatment initiation.

Serum HER-2 extracellular domain (ECD) before the first metastasis in 128 breast cancer patients.

We studied the serum HER-2 extracellular domain (sHER-2) before the first metastases in 128/701 breast cancer patients diagnosed and followed-up in our institution who developed metastases as the first relapse. sHER-2 was measured by an enzyme-linked immnunosorbent assay and CA 15.3 by an immunoradiometric assay.